Evaluating the Safety of and Immune Response to a Dengue Vaccine (TV003) in Healthy Adults, Adolescents, and Children in Thailand

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02332733
• Date of registration: 06/01/2015
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Evaluating the Safety of and Immune Response to a Dengue Vaccine (TV003) in Healthy Adults, Adolescents, and Children in Thailand
• Scientific title: Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Immunogenicity of Two Doses of the LID/NIAID Live-Attenuated Tetravalent Dengue Vaccine, TV003, Administered Six Months Apart, to Healthy Adults, Adolescents, and Children in Thailand
• Date of first enrolment: November 2014
• Target sample size: 266
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02332733
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Thailand

Contacts

• Name: Veerachai Watanaveeradej, MD
• Affiliation: Phramongkutklao College of Medicine and Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male or female participant between the ages of 12 months and 50 years at the
time of enrollment into the study

- Residence within the greater Bangkok area for the entire duration of the study period
with access to transportation to study site

- Participants and/or their parents/guardians who the investigator believes can and will
comply with the requirements of the protocol (e.g., completion of the diary cards,
return for follow-up visits)

- Participants who will remain available for the duration of the study, approximately 26
weeks post-second vaccination

- Good general health as determined by physical examination, laboratory screening, and
review of medical history

- If the participant is a minor, an assent form (for participant age 7-17 years) and
informed consent form signed and dated by minor and the participant's parent(s) or
legally acceptable representative, respectively. If the participant is 18 years of age
or older, an informed consent form signed and dated by the participant (and by an
independent witness if required by local regulations)

- If the participant is female, she must be of non-childbearing potential (i.e., either
pre-menarcheal, surgically sterilized, or one year post-menopausal), or, if of
childbearing potential, she must be abstinent or have used adequate contraceptive
precautions (i.e., intrauterine contraceptive device, condom and spermicide
combination, oral contraceptives or other equivalent hormonal contraception [e.g.,
progestin implantable, cutaneous hormonal patch, or injectable contraceptives]) for 30
days prior to vaccination, have a negative pregnancy test prior to vaccination, and
must agree to continue such precautions for 60 days after completion of the
vaccination series. Any child who begins menarche during the study period must follow
the same precautions listed above, from menarche until 60 days after the second
vaccine dose.

Exclusion Criteria:

- Pregnant or lactating female or female planning to become pregnant or planning to
discontinue abstinence or contraceptive precautions

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal,
autoimmune, hematologic, or endocrine disease or functional defect, as determined by
history, physical examination, or screening tests

- History of any neurological, psychiatric, or behavioral disorder or seizures, with the
exception of a single febrile seizure in childhood

- Self-reported or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or
equivalent, greater than or equal to 0.5 mg/kg/day or 20 mg/day, for more than 2
consecutive weeks within the past 3 months). Inhaled and topical steroids are allowed.

- Body weight less than 10 kg at the time of enrollment

- HIV infection by screening and confirmatory assays, hepatitis C virus (HCV) infection
by screening and confirmatory assays, or hepatitis B virus (HBV) infection by
hepatitis B surface antigen (HBsAg) screening

- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC),
alanine aminotransferase (ALT), or platelet count, as defined in this protocol

- History of allergic disease/reaction likely to be exacerbated by any component of the
vaccine; or any history of a severe allergic reaction or anaphylaxis

- Current alcohol abuse or drug addiction that might interfere with the ability to
comply with trial procedures

- Any other condition that in the opinion of the investigator would jeopardize the
safety or rights of a participant in the trial or would render the participant unable
to comply with the protocol

- Planned administration of any vaccine not foreseen by the study protocol, during the
period starting from 30 days before each dose of the study vaccine and ending 30 days
after each dose; with the exceptions of standard infant and child inactivated vaccines
and the inactivated influenza vaccine or the inactivated rabies vaccine (without
administration of immunoglobulin) administered to adults or children

- Use of any investigational or non-registered drug or vaccine other than the study
vaccine within 30 days preceding the first dose of study vaccine/placebo or planned
use at any time during the study period

- Administration of immunoglobulins and/or blood products within 90 days preceding the
first dose or planned administration at any time during the study period, which might
interfere with assessment of the immune response

- A planned or anticipated move to a location that will prohibit participating in the
trial for the full 12 month duration

- Potential adult participants or parents of potential child participants, who do not
have easy access to a fixed or mobile telephone

- Any participant identified as a site employee of the investigator or study clinic,
with direct involvement in the proposed study or other studies under the direction of
that investigator or study clinic, as well as any family member (i.e., immediate,
husband, wife and their children, adopted or natural) of the clinic employees or the
investigator



Age minimum: 12 Months
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dengue

Intervention(s)

Biological: TV003

Biological: Placebo for TV003

Primary Outcome(s)

Occurrence of serious adverse events (SAEs) throughout the entire study period [Time Frame: Measured through Day 360]

Serum plaque reduction neutralization titer 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses for each participant at baseline (Day 0) and Study Days 28, 56, 72, and 180 following each vaccination [Time Frame: Measured through Day 360]

Occurrence of solicited local and general adverse events (AEs) within the 21-day (Days 0-20) follow-up period after each vaccine dose [Time Frame: Measured through Day 200]

Occurrence of unsolicited AEs within the 21-day (Days 0-20) follow-up period after each vaccine dose [Time Frame: Measured through Day 200]

Secondary Outcome(s)

Duration of viremia of each monovalent component of the vaccine after the first and second doses of vaccine [Time Frame: Measured through Day 360]

Duration of the antibody response in recipients of the tetravalent vaccine [Time Frame: Measured through Day 360]

Frequency of viremia of each monovalent component of the vaccine after the first and second doses of vaccine [Time Frame: Measured through Day 360]

Number of vaccinees infected with DENV-1, DENV-2, DENV-3, and DENV-4 [Time Frame: Measured through Day 360]

Quantity of viremia of each monovalent component of the vaccine after the first and second doses of vaccine [Time Frame: Measured through Day 360]

Secondary ID(s)

WRAIR 2041

Source(s) of Monetary Support

Please refer to primary and secondary sponsors